The Florida Senate

499.012  Wholesale distribution; definitions; permits; applications; general requirements.--

(1)  As used in this section, the term:

(a)  "Wholesale distribution" means distribution of prescription drugs to persons other than a consumer or patient, but does not include:

1.  Any of the following activities, which is not a violation of s. 499.005(21) if such activity is conducted in accordance with s. 499.014:

a.  The purchase or other acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a prescription drug for its own use from the group purchasing organization or from other hospitals or health care entities that are members of that organization.

b.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug by a charitable organization described in s. 501(c)(3) of the Internal Revenue Code of 1986, as amended and revised, to a nonprofit affiliate of the organization to the extent otherwise permitted by law.

c.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug among hospitals or other health care entities that are under common control. For purposes of this section, "common control" means the power to direct or cause the direction of the management and policies of a person or an organization, whether by ownership of stock, by voting rights, by contract, or otherwise.

d.  The sale, purchase, trade, or other transfer of a prescription drug from or for any federal, state, or local government agency or any entity eligible to purchase prescription drugs at public health services prices pursuant to Pub. L. No. 102-585, s. 602 to a contract provider or its subcontractor for eligible patients of the agency or entity under the following conditions:

(I)  The agency or entity must obtain written authorization for the sale, purchase, trade, or other transfer of a prescription drug under this sub-subparagraph from the Secretary of Health or his or her designee.

(II)  The contract provider or subcontractor must be authorized by law to administer or dispense prescription drugs.

(III)  In the case of a subcontractor, the agency or entity must be a party to and execute the subcontract.

(IV)  A contract provider or subcontractor must maintain separate and apart from other prescription drug inventory any prescription drugs of the agency or entity in its possession.

(V)  The contract provider and subcontractor must maintain and produce immediately for inspection all records of movement or transfer of all the prescription drugs belonging to the agency or entity, including, but not limited to, the records of receipt and disposition of prescription drugs. Each contractor and subcontractor dispensing or administering these drugs must maintain and produce records documenting the dispensing or administration. Records that are required to be maintained include, but are not limited to, a perpetual inventory itemizing drugs received and drugs dispensed by prescription number or administered by patient identifier, which must be submitted to the agency or entity quarterly.

(VI)  The contract provider or subcontractor may administer or dispense the prescription drugs only to the eligible patients of the agency or entity or must return the prescription drugs for or to the agency or entity. The contract provider or subcontractor must require proof from each person seeking to fill a prescription or obtain treatment that the person is an eligible patient of the agency or entity and must, at a minimum, maintain a copy of this proof as part of the records of the contractor or subcontractor required under sub-sub-subparagraph (V).

(VII)  In addition to the departmental inspection authority set forth in s. 499.051, the establishment of the contract provider and subcontractor and all records pertaining to prescription drugs subject to this sub-subparagraph shall be subject to inspection by the agency or entity. All records relating to prescription drugs of a manufacturer under this sub-subparagraph shall be subject to audit by the manufacturer of those drugs, without identifying individual patient information.

2.  Any of the following activities, which is not a violation of s. 499.005(21) if such activity is conducted in accordance with rules established by the department:

a.  The sale, purchase, or trade of a prescription drug among federal, state, or local government health care entities that are under common control and are authorized to purchase such prescription drug.

b.  The sale, purchase, or trade of a prescription drug or an offer to sell, purchase, or trade a prescription drug for emergency medical reasons. For purposes of this sub-subparagraph, the term "emergency medical reasons" includes transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage.

c.  The transfer of a prescription drug acquired by a medical director on behalf of a licensed emergency medical services provider to that emergency medical services provider and its transport vehicles for use in accordance with the provider's license under chapter 401.

d.  The revocation of a sale or the return of a prescription drug to the person's prescription drug wholesale supplier.

e.  The donation of a prescription drug by a health care entity to a charitable organization that has been granted an exemption under s. 501(c)(3) of the Internal Revenue Code of 1986, as amended, and that is authorized to possess prescription drugs.

f.  The transfer of a prescription drug by a person authorized to purchase or receive prescription drugs to a person licensed or permitted to handle reverse distributions or destruction under the laws of the jurisdiction in which the person handling the reverse distribution or destruction receives the drug.

g.  The transfer of a prescription drug by a hospital or other health care entity to a person licensed under this chapter to repackage prescription drugs for the purpose of repackaging the prescription drug for use by that hospital, or other health care entity and other health care entities that are under common control, if ownership of the prescription drugs remains with the hospital or other health care entity at all times. In addition to the recordkeeping requirements of s. 499.0121(6), the hospital or health care entity that transfers prescription drugs pursuant to this sub-subparagraph must reconcile all drugs transferred and returned and resolve any discrepancies in a timely manner.

3.  The distribution of prescription drug samples by manufacturers' representatives or distributors' representatives conducted in accordance with s. 499.028

4.  The sale, purchase, or trade of blood and blood components intended for transfusion. As used in this subparagraph, the term "blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing, and the term "blood components" means that part of the blood separated by physical or mechanical means.

5.  The lawful dispensing of a prescription drug in accordance with chapter 465.

6.  The sale, purchase, or trade of a prescription drug between pharmacies as a result of a sale, transfer, merger, or consolidation of all or part of the business of the pharmacies from or with another pharmacy, whether accomplished as a purchase and sale of stock or of business assets.

(b)  "Wholesale distributor" means any person engaged in wholesale distribution of prescription drugs in or into this state, including, but not limited to, manufacturers; repackagers; own-label distributors; jobbers; private-label distributors; brokers; warehouses, including manufacturers' and distributors' warehouses, chain drug warehouses, and wholesale drug warehouses; independent wholesale drug traders; exporters; retail pharmacies; and the agents thereof that conduct wholesale distributions.

(c)  "Retail pharmacy" means a community pharmacy licensed under chapter 465 that purchases prescription drugs at fair market prices and provides prescription services to the public.

(d)  "Primary wholesaler" means any wholesale distributor that:

1.  Purchased 90 percent or more of the total dollar volume of its purchases of prescription drugs directly from manufacturers in the previous year; and

2.a.  Directly purchased prescription drugs from not fewer than 50 different prescription drug manufacturers in the previous year; or

b.  Has, or the affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member has, not fewer than 250 employees.

(e)  "Directly from a manufacturer" means:

1.  Purchases made by the wholesale distributor directly from the manufacturer of prescription drugs; and

2.  Transfers from a member of an affiliated group, as defined in s. 1504 of the Internal Revenue Code, of which the wholesale distributor is a member, if:

a.  The affiliated group purchases 90 percent or more of the total dollar volume of its purchases of prescription drugs from the manufacturer in the previous year; and

b.  The wholesale distributor discloses to the department the names of all members of the affiliated group of which the wholesale distributor is a member and the affiliated group agrees in writing to provide records on prescription drug purchases by the members of the affiliated group not later than 48 hours after the department requests access to such records, regardless of the location where the records are stored.

(f)  "Secondary wholesaler" means a wholesale distributor that is not a primary wholesaler.

(2)  The following types of wholesaler permits are established:

(a)  A prescription drug wholesaler's permit.--A prescription drug wholesaler is a wholesale distributor that may engage in the wholesale distribution of prescription drugs. A prescription drug wholesaler that applies to the department for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee's license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in ss. 499.001-499.081 which involves the permittee is concluded, including any appeal, whichever occurs later. The department may adopt rules for issuing a prescription drug wholesaler-broker permit to a person who engages in the wholesale distribution of prescription drugs and does not take physical possession of any prescription drugs.

(b)  A compressed medical gas wholesaler's permit.--A compressed medical gas wholesaler is a wholesale distributor that is limited to the wholesale distribution of compressed medical gases to other than the consumer or patient. The compressed medical gas must be in the original sealed container that was purchased by that wholesaler. A compressed medical gas wholesaler may not possess or engage in the wholesale distribution of any prescription drug other than compressed medical gases. The department shall adopt rules that govern the wholesale distribution of prescription medical oxygen for emergency use. With respect to the emergency use of prescription medical oxygen, those rules may not be inconsistent with rules and regulations of federal agencies unless the Legislature specifically directs otherwise.

(c)  An out-of-state prescription drug wholesaler's permit.--An out-of-state prescription drug wholesaler is a wholesale distributor located outside this state which engages in the wholesale distribution of prescription drugs into this state and which must be permitted by the department and comply with all the provisions required of a wholesale distributor under ss. 499.001-499.081. An out-of-state prescription drug wholesaler that applies to the department for a new permit or the renewal of a permit must submit a bond of $100,000, or other equivalent means of security acceptable to the department, such as an irrevocable letter of credit or a deposit in a trust account or financial institution, payable to the Florida Drug, Device, and Cosmetic Trust Fund. The purpose of the bond is to secure payment of any administrative penalties imposed by the department and any fees and costs incurred by the department regarding that permit which are authorized under state law and which the permittee fails to pay 30 days after the fine or costs become final. The department may make a claim against such bond or security until 1 year after the permittee's license ceases to be valid or until 60 days after any administrative or legal proceeding authorized in ss. 499.001-499.081 which involves the permittee is concluded, including any appeal, whichever occurs later.

1.  The out-of-state drug wholesaler must maintain at all times a license or permit to engage in the wholesale distribution of prescription drugs in compliance with laws of the state in which it is a resident.

2.  An out-of-state prescription drug wholesaler's permit is not required for an intracompany sale or transfer of a prescription drug from an out-of-state establishment that is duly licensed as a prescription drug wholesaler, in its state of residence, to a licensed prescription drug wholesaler in this state, if both wholesalers conduct wholesale distributions of prescription drugs under the same business name. The recordkeeping requirements of s. 499.0121(6) must be followed for this transaction.

(d)  A retail pharmacy wholesaler's permit.--A retail pharmacy wholesaler is a retail pharmacy engaged in wholesale distribution of prescription drugs within this state under the following conditions:

1.  The pharmacy must obtain a retail pharmacy wholesaler's permit pursuant to ss. 499.001-499.081 and the rules adopted under those sections.

2.  The wholesale distribution activity does not exceed 30 percent of the total annual purchases of prescription drugs. If the wholesale distribution activity exceeds the 30-percent maximum, the pharmacy must obtain a prescription drug wholesaler's permit.

3.  The transfer of prescription drugs that appear in any schedule contained in chapter 893 is subject to chapter 893 and the federal Comprehensive Drug Abuse Prevention and Control Act of 1970.

4.  The transfer is between a retail pharmacy and another retail pharmacy, or a Modified Class II institutional pharmacy, or a health care practitioner licensed in this state and authorized by law to dispense or prescribe prescription drugs.

5.  All records of sales of prescription drugs subject to this section must be maintained separate and distinct from other records and comply with the recordkeeping requirements of ss. 499.001-499.081.

(e)  Nonresident prescription drug manufacturer permit.--A nonresident prescription drug manufacturer permit is required for any person that is a manufacturer of prescription drugs, or the distribution point for a manufacturer of prescription drugs, and located outside of this state, or that is an entity to whom an approved new drug application has been issued by the United States Food and Drug Administration, or the contracted manufacturer of the approved new drug application holder, and located outside the United States, which engages in the wholesale distribution in this state of the prescription drugs it manufactures or is responsible for manufacturing. Each such manufacturer or entity must be permitted by the department and comply with all the provisions required of a wholesale distributor under ss. 499.001-499.081, except s. 499.0121(6)(d), (e), or (f).

1.  A person that distributes prescription drugs that it did not manufacture must also obtain an out-of-state prescription drug wholesaler permit pursuant to this section to engage in the wholesale distribution of the prescription drugs manufactured by another person and comply with the requirements of an out-of-state prescription drug wholesaler.

2.  Any such person must comply with the licensing or permitting requirements of the jurisdiction in which the establishment is located and the federal act, and any product wholesaled into this state must comply with ss. 499.001-499.081. If a person intends to import prescription drugs from a foreign country into this state, the nonresident prescription drug manufacturer must provide to the department a list identifying each prescription drug it intends to import and document approval by the United States Food and Drug Administration for such importation.

(f)  Freight forwarder permit.--A freight forwarder permit is required for any person that engages in the distribution of a legend drug as a freight forwarder unless the person is a common carrier. The storage, handling, and recordkeeping of such distributions must comply with the requirements for wholesale distributors under s. 499.0121, except those set forth in s. 499.0121(6)(d), (e), or (f). A freight forwarder must provide the source of the legend drugs with a validated airway bill, bill of lading, or other appropriate documentation to evidence the exportation of the product.

(g)  A veterinary prescription drug wholesaler permit.--A veterinary prescription drug wholesaler permit is required for any person that engages in the distribution of veterinary prescription drugs in or into this state. A veterinary prescription drug wholesaler that also distributes prescription drugs subject to, defined by, or described by s. 503(b) of the Federal Food, Drug, and Cosmetic Act which it did not manufacture must obtain a permit as a prescription drug wholesaler or out-of-state prescription drug wholesaler in lieu of the veterinary prescription drug wholesaler permit. A veterinary prescription drug wholesaler must comply with the requirements for wholesale distributors under s. 499.0121, except those set forth in s. 499.0121(6)(d), (e), or (f).

(3)  An application for a permit or to renew a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler submitted to the department must include:

(a)  The name, full business address, and telephone number of the applicant.

(b)  All trade or business names used by the applicant.

(c)  The address, telephone numbers, and the names of contact persons for each facility used by the applicant for the storage, handling, and distribution of prescription drugs.

(d)  The type of ownership or operation, such as a partnership, corporation, or sole proprietorship.

(e)  The names of the owner and the operator of the establishment, including:

1.  If an individual, the name of the individual.

2.  If a partnership, the name of each partner and the name of the partnership.

3.  If a corporation:

a.  The name, address, and title of each corporate officer and director.

b.  The name and address of the corporation, resident agent of the corporation, the resident agent's address, and the corporation's state of incorporation.

c.  The name and address of each shareholder of the corporation that owns 5 percent or more of the outstanding stock of the corporation.

4.  If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.

5.  If a limited liability company:

a.  The name and address of each member.

b.  The name and address of each manager.

c.  The name and address of the limited liability company, the resident agent of the limited liability company, and the name of the state in which the limited liability company was organized.

(f)  If applicable, the name and address of each member of the affiliated group of which the applicant is a member.

(g)1.  For an application for a new permit, the estimated annual dollar volume of prescription drug sales of the applicant, the estimated annual percentage of the applicant's total company sales that are prescription drugs, the applicant's estimated annual total dollar volume of purchases of prescription drugs, and the applicant's estimated annual total dollar volume of prescription drug purchases directly from manufacturers.

2.  For an application to renew a permit, the total dollar volume of prescription drug sales in the previous year, the total dollar volume of prescription drug sales made in the previous 6 months, the percentage of total company sales that were prescription drugs in the previous year, the total dollar volume of purchases of prescription drugs in the previous year, and the total dollar volume of prescription drug purchases directly from manufacturers in the previous year.

Such portions of the information required pursuant to this paragraph which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information is required to be maintained under s. 499.051

(h)  The tax year of the applicant.

(i)  A copy of the deed for the property on which applicant's establishment is located, if the establishment is owned by the applicant, or a copy of the applicant's lease for the property on which applicant's establishment is located that has an original term of not less than 1 calendar year, if the establishment is not owned by the applicant.

(j)  A list of all licenses and permits issued to the applicant by any other state which authorize the applicant to purchase or possess prescription drugs.

(k)  The name of the manager of the establishment that is applying for the permit or to renew the permit, the next four highest ranking employees responsible for prescription drug wholesale operations for the establishment, and the name of all affiliated parties for the establishment, together with the personal information statement and fingerprints required pursuant to subsection (4) for each of such persons.

(l)  The name of each of the applicant's designated representatives as required by subsection (11), together with the personal information statement and fingerprints required pursuant to subsection (4) for each such person.

(m)  For an applicant that is a secondary wholesaler, each of the following:

1.  A personal background information statement containing the background information and fingerprints required pursuant to subsection (4) for each person named in the applicant's response to paragraphs (k) and (l) and for each affiliated party of the applicant.

2.  If any of the five largest shareholders of the corporation seeking the permit is a corporation, the name, address, and title of each corporate officer and director of each such corporation; the name and address of such corporation; the name of such corporation's resident agent, such corporation's resident agent's address, and such corporation's state of its incorporation; and the name and address of each shareholder of such corporation that owns 5 percent or more of the stock of such corporation.

3.  The name and address of all financial institutions in which the applicant has an account which is used to pay for the operation of the establishment or to pay for drugs purchased for the establishment, together with the names of all persons that are authorized signatories on such accounts. The portions of the information required pursuant to this subparagraph which are a trade secret, as defined in s. 812.081, shall be maintained by the department as trade secret information is required to be maintained under s. 499.051

4.  The sources of all funds and the amounts of such funds used to purchase or finance purchases of prescription drugs or to finance the premises on which the establishment is to be located.

5.  If any of the funds identified in subparagraph 4. were borrowed, copies of all promissory notes or loans used to obtain such funds.

(n)  Any other relevant information that the department requires, including, but not limited to, any information related to whether the applicant satisfies the definition of a primary wholesaler or a secondary wholesaler.

(4)(a)  Each person required by subsection (3) to provide a personal information statement and fingerprints shall provide the following information to the department on forms prescribed by the department:

1.  The person's places of residence for the past 7 years.

2.  The person's date and place of birth.

3.  The person's occupations, positions of employment, and offices held during the past 7 years.

4.  The principal business and address of any business, corporation, or other organization in which each such office of the person was held or in which each such occupation or position of employment was carried on.

5.  Whether the person has been, during the past 7 years, the subject of any proceeding for the revocation of any license and, if so, the nature of the proceeding and the disposition of the proceeding.

6.  Whether, during the past 7 years, the person has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating any federal or state law regulating the possession, control, or distribution of prescription drugs, together with details concerning any such event.

7.  A description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund, during the past 7 years, which manufactured, administered, prescribed, distributed, or stored pharmaceutical products and any lawsuits in which such businesses were named as a party.

8.  A description of any felony criminal offense of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere. A criminal offense committed in another jurisdiction which would have been a felony in this state must be reported. If the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of that criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the department a copy of the final written order of disposition.

9.  A photograph of the person taken in the previous 30 days.

10.  A set of fingerprints for the person on a form and under procedures specified by the department, together with payment of an amount equal to the costs incurred by the department for the criminal record check of the person.

11.  The name, address, occupation, and date and place of birth for each member of the person's immediate family who is 18 years of age or older. As used in this subparagraph, the term "member of the person's immediate family" includes the person's spouse, children, parents, siblings, the spouses of the person's children, and the spouses of the person's siblings.

12.  Any other relevant information that the department requires.

(b)  The information required pursuant to paragraph (a) shall be provided under oath.

(c)  The department shall submit the fingerprints provided by a person for initial licensure to the Department of Law Enforcement for a statewide criminal record check and for forwarding to the Federal Bureau of Investigation for a national criminal record check of the person. The department shall submit the fingerprints provided by a person as a part of a renewal application to the Department of Law Enforcement for a statewide criminal record check, and for forwarding to the Federal Bureau of Investigation for a national criminal record check, for the initial renewal of a permit after January 1, 2004; for any subsequent renewal of a permit, the department shall submit the required information for a statewide and national criminal record check of the person. Any person who as a part of an initial permit application or initial permit renewal after January 1, 2004, submits to the department a set of fingerprints required for the criminal record check required in this paragraph shall not be required to provide a subsequent set of fingerprints for a criminal record check to the department, if the person has undergone a criminal record check as a condition of the issuance of an initial permit or the initial renewal of a permit of an applicant after January 1, 2004.

(5)  The department may deny an application for a permit or refuse to renew a permit for a prescription drug wholesaler or an out-of-state prescription drug wholesaler if:

(a)  The applicant has not met the requirements for the permit.

(b)  The management, officers, or directors of the applicant or any affiliated party are found by the department to be incompetent or untrustworthy.

(c)  The applicant is so lacking in experience in managing a wholesale distributor as to make the issuance of the proposed permit hazardous to the public health.

(d)  The applicant is so lacking in experience in managing a wholesale distributor as to jeopardize the reasonable promise of successful operation of the wholesale distributor.

(e)  The applicant is lacking in experience in the distribution of prescription drugs.

(f)  The applicant's past experience in manufacturing or distributing prescription drugs indicates that the applicant poses a public health risk.

(g)  The applicant is affiliated directly or indirectly through ownership, control, or other business relations, with any person or persons whose business operations are or have been detrimental to the public health.

(h)  The applicant, or any affiliated party, has been found guilty of or has pleaded guilty or nolo contendere to any felony or crime punishable by imprisonment for 1 year or more under the laws of the United States, any state, or any other country, regardless of whether adjudication of guilt was withheld.

(i)  The applicant or any affiliated party has been charged with a felony in a state or federal court and the disposition of that charge is pending during the application review or renewal review period.

(j)  The applicant has furnished false or fraudulent information or material in any application made in this state or any other state in connection with obtaining a permit or license to manufacture or distribute drugs, devices, or cosmetics.

(k)  That a federal, state, or local government permit currently or previously held by the applicant, or any affiliated party, for the manufacture or distribution of any drugs, devices, or cosmetics has been disciplined, suspended, or revoked and has not been reinstated.

(l)  The applicant does not possess the financial or physical resources to operate in compliance with the permit being sought, this chapter, and the rules adopted under this chapter.

(m)  The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who was an affiliated party of a permittee whose permit was subject to discipline or was suspended or revoked, other than through the ownership of stock in a publicly traded company or a mutual fund.

(n)  The applicant or any affiliated party receives, directly or indirectly, financial support and assistance from a person who has been found guilty of any violation of ss. 499.001-499.081 or chapter 465, chapter 501, or chapter 893, any rules adopted under any of those sections or chapters, any federal or state drug law, or any felony where the underlying facts related to drugs, regardless of whether the person has been pardoned, had her or his civil rights restored, or had adjudication withheld, other than through the ownership of stock in a publicly traded company or a mutual fund.

(o)  The applicant for renewal of a permit under paragraph (2)(a) or paragraph (2)(c) has not actively engaged in the wholesale distribution of prescription drugs, as demonstrated by the regular and systematic distribution of prescription drugs throughout the year as evidenced by not fewer than 12 wholesale distributions in the previous year and not fewer than three wholesale distributions in the previous 6 months.

(p)  Information obtained in response to paragraph (2)(a) or paragraph (2)(c) demonstrates it would not be in the best interest of the public health, safety, and welfare to issue a permit.

(q)  The applicant does not possess the financial standing and business experience for the successful operation of the applicant.

(r)  The applicant or any affiliated party has failed to comply with the requirements for manufacturing or distributing prescription drugs under ss. 499.001-499.081, similar federal laws, similar laws in other states, or the rules adopted under such laws.

(6)  Upon approval of the application by the department and payment of the required fee, the department shall issue or renew a prescription drug wholesaler or an out-of-state prescription drug wholesaler permit to the applicant.

(7)  For permits for prescription drug wholesalers or out-of-state prescription drug wholesalers:

(a)  The department shall adopt rules for the annual renewal of permits. At least 90 days before the expiration of a permit, the department shall forward a permit renewal notification and renewal application to the prescription drug wholesaler or out-of-state prescription drug wholesaler at the mailing address of the permitted establishment on file with the department. The permit renewal notification must state conspicuously the date on which the permit for the establishment will expire and that the establishment may not operate unless the permit for the establishment is renewed timely.

(b)  A permit, unless sooner suspended or revoked, automatically expires 1 year after the last day of the anniversary month in which the permit was originally issued. A permit may be renewed by making application for renewal on forms furnished by the department and paying the appropriate fees. If a renewal application and fee are submitted and postmarked after 45 days prior to the expiration date of the permit, the permit may be renewed only upon payment of a late renewal fee of $100, plus the required renewal fee. A permittee that has submitted a renewal application in accordance with this paragraph may continue to operate under its permit, unless the permit is suspended or revoked, until final disposition of the renewal application.

(c)  Failure to renew a permit in accordance with this section precludes any future renewal of that permit. If a permit issued pursuant to this section has expired and cannot be renewed, before an establishment may engage in activities that require a permit under ss. 499.001-499.081, the establishment must submit an application for a new permit; pay the applicable application fee, initial permit fee, and all applicable penalties; and be issued a new permit by the department.

(8)  A person that engages in wholesale distribution of prescription drugs in this state must have a wholesale distributor's permit issued by the department, except as noted in this section. Each establishment must be separately permitted except as noted in this subsection.

(a)  A separate establishment permit is not required when a permitted prescription drug wholesaler consigns a prescription drug to a pharmacy that is permitted under chapter 465 and located in this state, provided that:

1.  The consignor wholesaler notifies the department in writing of the contract to consign prescription drugs to a pharmacy along with the identity and location of each consignee pharmacy;

2.  The pharmacy maintains its permit under chapter 465;

3.  The consignor wholesaler, which has no legal authority to dispense prescription drugs, complies with all wholesale distribution requirements of s. 499.0121 with respect to the consigned drugs and maintains records documenting the transfer of title or other completion of the wholesale distribution of the consigned prescription drugs;

4.  The distribution of the prescription drug is otherwise lawful under this chapter and other applicable law;

5.  Open packages containing prescription drugs within a pharmacy are the responsibility of the pharmacy, regardless of how the drugs are titled; and

6.  The pharmacy dispenses the consigned prescription drug in accordance with the limitations of its permit under chapter 465 or returns the consigned prescription drug to the consignor wholesaler. In addition, a person who holds title to prescription drugs may transfer the drugs to a person permitted or licensed to handle the reverse distribution or destruction of drugs. Any other distribution by and means of the consigned prescription drug by any person, not limited to the consignor wholesaler or consignee pharmacy, to any other person is prohibited.

(b)  A wholesale distributor's permit is not required for the one-time transfer of title of a pharmacy's lawfully acquired prescription drug inventory by a pharmacy with a valid permit issued under chapter 465 to a consignor prescription drug wholesaler, permitted under this chapter, in accordance with a written consignment agreement between the pharmacy and that wholesaler if: the permitted pharmacy and the permitted prescription drug wholesaler comply with all of the provisions of paragraph (a) and the prescription drugs continue to be within the permitted pharmacy's inventory for dispensing in accordance with the limitations of the pharmacy permit under chapter 465. A consignor drug wholesaler may not use the pharmacy as a wholesale distributor through which it distributes the legend drugs to other pharmacies. Nothing in this section is intended to prevent a wholesale drug distributor from obtaining this inventory in the event of nonpayment by the pharmacy.

(c)  The department shall require information from each wholesale distributor as part of the permit and renewal of such permit, as required under s. 499.01 or this section.

(9)  Personnel employed in wholesale distribution must have appropriate education and experience to enable them to perform their duties in compliance with state permitting requirements.

(10)  The name of a permittee or establishment on a prescription drug wholesaler permit or an out-of-state prescription drug wholesaler permit may not include any indicia of attainment of any educational degree, any indicia that the permittee or establishment possesses a professional license, or any name or abbreviation that the department determines is likely to cause confusion or mistake or that the department determines is deceptive, including that of any other entity authorized to purchase prescription drugs.

(11)(a)  Each establishment that is issued an initial or renewal permit as a prescription drug wholesaler or an out-of-state prescription drug wholesaler must designate in writing to the department at least one natural person to serve as the designated representative of the wholesaler. Such person must have an active certification as a designated representative from the department.

(b)  To be certified as a designated representative, a natural person must:

1.  Submit an application on a form furnished by the department and pay the appropriate fees;

2.  Be at least 18 years of age;

3.  Have not less than 2 years of verifiable full-time work experience in a pharmacy licensed in this state or another state, where the person's responsibilities included, but were not limited to, recordkeeping for prescription drugs, or have not less than 2 years of verifiable full-time managerial experience with a prescription drug wholesaler licensed in this state or in another state;

4.  Receive a passing score of at least 75 percent on an examination given by the department regarding federal laws governing distribution of prescription drugs and ss. 499.001-499.081 and the rules adopted by the department governing the wholesale distribution of prescription drugs. This requirement shall be effective 1 year after the results of the initial examination are mailed to the persons that took the examination. The department shall offer such examinations at least four times each calendar year; and

5.  Provide the department with a personal information statement and fingerprints pursuant to subsection (4).

(c)  The department may deny an application for certification as a designated representative or may suspend or revoke a certification of a designated representative pursuant to s. 499.067

(d)  A designated representative:

1.  Must be actively involved in and aware of the actual daily operation of the wholesale distributor.

2.  Must be employed full time in a managerial position by the wholesale distributor.

3.  Must be physically present at the establishment during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence.

4.  May serve as a designated representative for only one wholesale distributor at any one time.

(e)  A wholesale distributor must notify the department when a designated representative leaves the employ of the wholesale distributor. Such notice must be provided to the department within 10 business days after the last day of designated representative's employment with the wholesale distributor.

(f)  A wholesale distributor may not operate under a prescription drug wholesaler permit or an out-of-state prescription drug wholesaler permit for more than 10 business days after the designated representative leaves the employ of the wholesale distributor, unless the wholesale distributor employs another designated representative and notifies the department within 10 business days of the identity of the new designated representative.

(12)  The department may adopt rules governing the recordkeeping, storage, and handling with respect to each of the distributions of prescription drugs specified in subparagraphs (1)(a)1.-4.

History.--s. 15, ch. 92-69; s. 187, ch. 97-264; s. 31, ch. 98-151; s. 172, ch. 99-397; s. 20, ch. 2001-53; s. 138, ch. 2001-277; s. 38, ch. 2002-400; ss. 13, 14, ch. 2003-155; s. 3, ch. 2004-328; s. 2, ch. 2005-248.